Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2020 | ICU Medical, Inc. 7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(30)50(10)4558474.
The Intravascular Administratio Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254;
(01)108 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case.
UDI: (01)10840619061231(17)250201(30)50(10)4734990.
Administration sets and their ac Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666.
Administratio Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per case.
UDI:(01)10840619093195(17)250101(30)50(10)4600271; (01)10840619093195(17)2412 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case.
UDI: (01)10840619083929(17)241201(30)50(10)4496182.
Administration sets and t Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap. 1 unit per pouch, 2 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case.
UDI:(01)10840619062761(17)241201(30)50(10)4553703.
Administration sets and thei Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250101(30)50(10)4584874;
(01)10840619092754(17)250101( Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case.
UDI:(01)10840619076174(17)250201(30)50(10)4735112; (01)10840619076174(17)241201(30) Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case.
UDI:(01)10840619060616(17)250201(30)25(10)4711366.
A Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case.
UDI: (01)10840619066052(17)250201(30)50(10)4717491.
Administration sets and their accessorie Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10840619066014(17)250201(30)50(10)4718521;(01)1 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter.
1 unit per pouch, 50 pouches per case.
UDI: (01)10840619059801(17)250201(30)50(10)4718517;
(01)10840619059801(17)241201(30)50(10)4514500;
(01)1084 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case.
UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)471135 Terminated |
FPA | None listed |
| Jul 6, 2020 | ICU Medical, Inc. 8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709085814(17)250101(30)50(10)4605676.
CLAVE Neutron is a normally closed, Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case.
UDI:(01)10887709058757(17)250101(30)100(10)4573278;
(01)10887709058757(17)250101(30)100(10)4590919;
(01)10887709058757(17)250201(3 Terminated |
FPA | K100434 |
| Jul 6, 2020 | ICU Medical, Inc. 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034959(17)250201(30)25( Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case.
UDI:(01)1088770907 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862.
The SmartValve is a single use, ster Terminated |
FPA | K974589 |
| Jul 6, 2020 | ICU Medical, Inc. 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case.
UDI:(01)10887709074696(17)250101(30)25(10)4711277;(01)10887709074696(1 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841.
The Intravascular Administrati Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10887709051967(17)2502 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442.
The Intravascular Administration Set Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709040141(17)250101(30)25(10)4573652.
The SmartValve Terminated |
FPA | K974589 |
| Jul 6, 2020 | ICU Medical, Inc. 60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)4726780.
The Intravascular Administration Set is Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709039916(17)250201(30)50(10)4727496.
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids th Terminated |
FPA | K080077 |
| Jul 6, 2020 | ICU Medical, Inc. 6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)10887709079877(17)250101(30)5 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case.
UDI:(01)10887709098878(17)241201(30)50(10)4493149.
The ChemoClave is a Terminated |
FPA | K173477 |
| Jul 6, 2020 | ICU Medical, Inc. 7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133.
The Intravascular Administration Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709014531(17)250101(30)50(10)4603496.
The In Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709062365(17)250201(30)25(10)4630752.
The Intravascular Administrati Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709011691(17)250201( Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case.
UDI:(01)10887709121703(17)250201(30)50(10)4723226.
The Intravascular A Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(17)250101(30)50(10)4 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)250101(30)50(10)4573963; Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709088354(17)250101(30)50(10)4557643.
The Intravascular Administratio Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709070551(17)241201(30)50(10)4542066;
(01)10887709070551(17)241201(30)50(10)4549203;
(01)10887 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case.
UDI:(01)10887709069203(17)250201(30)50(10)4742130;
(01)10887709069203(17)250401(30)50(10)48 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709067582(17)241201(30)50(10)4548270;
(01)10887709067582(17)250101(30)50 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709067322(17)250101(30)50(10)4565730;
(01)10887709067322(17)250201(30)50(10)4 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case.
UDI:(01)10887709121154(17)250101(30)25(10)4556714;
(01)10887709121154(17)2 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121147(17)250101 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709095298(17)250101(30)25(10)4573460;
(01)10887709095298 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709080796(17)241201(30)50(10)4536743;
(01)10887709080796(17)250101(30)50 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per case.
UDI:(01)108877 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328.
The Intravascular Adminis Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709089904(17)250101(30)25(10)4713954.
The Intravascular Terminated |
FPA | K964435 |
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